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Clinical Trials/NCT01312532
NCT01312532CompletedPhase 2

Study of Prosthesis in Total Knee Arthroplasty

Isfahan University of Medical Sciences1 site in 1 country100 target enrollmentStarted: June 2004Last updated:
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Conditions

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
100
Locations
1
Primary Endpoint
Knee Society Scoring
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The purpose of this study is to determine which prosthesis is better in total knee arthroplasty

Detailed Description

Theoretical advantages of mobile-bearing devices led surgeons to use these prostheses instead of fixed-bearing devices as traditional implants. This study was designed to compare Fixed-bearing versus Mobile-bearing Prosthesis in Total Knee Arthroplasty through a five-year follow-up.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Patients with expected primary total knee arthroplasty

Exclusion Criteria

  • •Mediolateral instability
  • •Infective arthritis
  • •Severe deformity

Outcomes

Primary Outcomes

Knee Society Scoring

Time Frame: five years after surgery

was used for evaluating the function of the knee and high scores indicated better knee function

Secondary Outcomes

  • Pain(five years after surgery)

Investigators

Sponsor Class
Other

Study Sites (1)

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